Intra cardiac device, system and methods

ABSTRACT

An intra cardiac device transforms kinetic energy from heart tissue movement into electrical energy to power the device and provide information in respect of heart function. A system comprising such an intra cardiac device may communicate wirelessly with at least one receiver outside the body and may be used for conveniently monitoring or stimulating a patient&#39;s heart.

RELATED APPLICATIONS

The present invention claims benefit of International Application No.PCT/EP2005/056700, filed 12 Dec. 2005, entitled Intra Cardiac Device,System And Methods, which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention refers to an intra cardiac device and methods forheart function intervention, such as monitoring and controlling of saidheart function.

BACKGROUND OF THE INVENTION

Congestive heart failure (CHF) is a condition where the heart is notable to pump enough blood to supply the body with energy and oxygen.There are multiple causes for the heart to fail, such as ischemic heartdisease caused by clogged arteries, cardiomyopathy of unknown reasons orend stage after congenital heart diseases or heart valve diseases. Withan increasing aging of the population today, the problem of CHF isincreasing and is now the most common cause of heart disease mortality.According to the American Heart Association 5 million people in theUnited States experience CHF, increasing in number by half a millionevery year. 1% of the population over 50 years of age or 5% of the morethan 75 years old are affected by the condition of CHF. Worldwide thenumber of people suffering from CHD is estimated around 20 million.Independent of what the reason for CHD, the symptoms and the treatmentare the same. The failing pump function causes low blood pressure andlow cardiac output resulting in renal failure, and a lower urineproduction causes fluid retention in the body.

A failing left ventricle of the heart causes the blood to be stagnant inthe lungs, causing slow flow and high pressures in the blood stream ofthe lungs. As a result thereof, fluid will be pressed from the bloodvessels into the lung tissue resulting in a decreased gas exchange inthe lungs, a condition that worsens the heart condition.

A right heart failure on the other hand causes slow flow and stagnationof blood in the vein system of the body. As a result thereof, fluid ispressed from the small blood vessels, the capillaries, into the variousorgan tissues including the fatty tissue under the skin. This fluidretention causes for instance weight gain, swollen organs and legs andshortness of breath.

The treatment of CHF is first of all a correction of the underlyingcauses such as valvular disease or coronary artery blocks. However, forthe majority of patients this treatment is too late. Surgically, onlyheart transplantation and implantation of mechanical heart assistdevices are available. However, only 2-3000 heart transplants are madeworldwide in the youngest population, due to lack of donor organs. Also,mechanical assist devices are still experimental. Therefore the majorityof the patients are left with symptomatic medical treatment. First ofall fluid restriction and treatment with diuretics are used. Other drugsare Angiotensin-converting Enzyme (ACE) inhibitors, beta-blockers anddigitalis. Most of CHF patients live for a long time before dying andare readmitted again and again in order to adjust medication or getdiuretics injected. Changes in the heart movements, the volumes and thepressures occur fast. The symptoms, however, appear slowly, resulting intreatment too late.

Previously, Medtronic Inc. has introduced the Chronicle device, animplantable Hemodynamic Monitor. That system contains a Lithium batteryand a computing element to be implanted under the skin, remote from theheart. Further, this unit has a lead with a pressure transducer thatextends into the heart where it can measure intra cardiac pressure, anindirect indicator when diagnosing a heart condition. The Chronicle unitis capable of using several algorithms to present curves and trends thatcan be detected in a receiver outside the body.

Savacor Inc. has developed the HeartPOD™, a very similar product to theChronicle device, the major difference being that the transducer locatedat the tip of a lead is implanted in the atrial septum wall measuringthe pressure in the left atrium. A handheld computer serves as a patientmonitor receiving physiological signals from an implant by wirelesstransmission. Savacor's technology is based on apparatus and methods asdescribed in U.S. Pat. No. 6,328,699.

U.S. Pat. No. 6,328,699 discloses an apparatus for treating congestiveheart failure in a patient. However, this apparatus is provided with apressure transducer lead that is permanently implanted in the leftatrium of the patients heart. This pressure transducer lead is connectedto an electrical circuitry for processing electrical signals. Thus, theapparatus according to U.S. Pat. No. 6,328,699 has the disadvantage ofpresenting a lead (or wire) inside the body (and inside the heart) ofthe patient, rendering the apparatus inferior in respect of a device inno need of such a lead, said device being fully implantable in the bodyof the patient. Moreover, the device according to U.S. Pat. No.6,328,699 receives energy from a battery, which renders it inferior inncomparison to a device in no need of a battery.

Remon Medical Technologies Inc. has introduced a device for non-invasiveassessment of pulmonary artery pressure. A pressure transducer isinserted into the pulmonary artery and fixed there. The pressuretransducer is connected to an implanted remote device collecting datafrom the implanted transducer. Ultrasound energy is applied from outsidethe body in order to activate and energize the device. Wirelesscommunication to an external unit is also supported when the device ispowered-up.

CardioMEMS Inc. on the other hand has developed a similar system thatcan measure pressure by means of an un-powered, permanently implantablepressure sensor, which is energized by means of high frequency radiowaves from outside the body. The pressure sensor is intended formeasuring intrasac pressure during endovascular abdominal aorticaneurysm (AAA) repair.

Disturbances of the Heart Rhythm

Pacemakers (PM) are electronic devices to be implanted in a human bodywith the purpose to regulate the heart beat and the heart rhythm bymeans of electrical stimuli in patients that have lost the ability toregulate the heart rhythm, e.g. a heart block is such a condition. A PM36, e.g. shown in FIG. 2, is a hermetically sealed metal can 38 thatcontains a battery 40 and an electronic circuit. The PM can is implantedin the body under the skin at a remote site from the heart. The PMdelivers electrical stimuli to the heart by means of an electrical lead42, or multiple electrical leads 42, extending from the PM can 38 in oneend to a heart tissue and in the other end having an un-insulatedelectrode tip 44 or another form of transducer at tip 44, respectively.

Rune Elmqvist, a Swedish engineer designed the first implantable PM, andDr. Aake Senning implanted the device into the body of the patient ArneLarsson in 1958. The patient lived for 43 years after the first implantand had additionally 23 different PMs implanted during his lifetime.This first PM had a battery that was rechargeable, the first nonrechargeable PM was developed simultaneously by Dr. Greatbach in USA andwas implanted for the first time in 1960. Today only non-rechargeablePMs are used. The PM industry today is among the most profitable in themedical device area, more than 600,000 PMs are produced yearly. Somemodern PMs are able also to detect irregular, sometimes life-threateningirregularities in the heart rhythm, also known as arrhythmia. Over time,PMs were combined with a defibrillator, called an implantablecardioverter defibrillator (ICD), to correct such arrhythmia by means ofan electrical shock.

Generally, there are two main problems with PM treatment today, relatedto the leads and to the battery.

The leads are insulated cables, connected hermetically sealed to theelectronic circuit in the PM can in one end and connected to the hearttissue with an un-insulated end, the electrode tip, in the other end.The tip is made of material that facilitates in-growth in the hearttissue. The insulation is made of medical quality polymers, usuallypolyurethane and is made as thin as possible in order to save space. Theinsulation must be absolutely impermeable. If not, electrical leakcurrents will occur and the PM will not function. The core of the lead,the electrically conducting part, is made of a metal that is a goodelectrical conductor. Since the heart is constantly bending andtwisting, the metal in the conductor has to be very tolerant to bendingwithout fracturing, a fracture occurs frequently and stops the electrontransfer and the PM does not function. Lead infection is another largeproblem. Furthermore, the leads are immersed in the blood stream, aperfect environment for bacteria, and in contact with subcutaneoustissue, a common site for infections, especially from the PM can pocket.Bacteria easily migrate from the skin to subcutaneous tissue and intothe blood stream along the leads. Finally lead tips often dislocate fromthe heart tissue, loosing contact to the heart cells, and thereby noelectron transfer to the heart tissue is possible. Insulation defects,conductor fracture, infections, and tip dislocations are some of the PMrelated issues that result in recurrent surgical operations, usuallyincluding additional leads being put in, since retrieval of previouslyimplanted leads is very difficult if not impossible in many cases. Thuspatients normally end up having many leads, most of them not in use.When more complex devices are used, like an ICD or a PM that stimulatesand detects at different sites in the heart (e.g. atrium and ventricle)a system may consist of up to four leads at implant, each of them proneto the problems described above.

The Battery

Different energy sources have been explored for batteries, inclusivenuclear. However, only Lithium (Li) batteries have proven to functionwell in PMs and today this energy source is exclusively used. Like allbatteries the main problem is durability. The electrons will only flowthrough a closed circuit, from the negative pole of a battery throughthe load, i.e. the body, back to the positive pole of a battery, andthen through the battery (electrical current is described in theopposite direction). Electrons returning to the battery join with Iodineand then with Lithium to Lithium-Iodine (LiI), which is not a goodelectron conductor. Buildup of LiI increases the internal resistance ina Li battery. Increasing internal resistance causes a decreasing batteryvoltage and finally the available voltage becomes insufficient tostimulate the heart and the battery is useless. A Li battery willdeliver at its beginning-of-life around 2.8 V and in the best case itwill have a linear output for 5 years. From this time the internalresistance increases exponentially, and when the voltage comes down toclose to the heart stimulation threshold, the battery has to bereplaced. A Li battery will normally contain 2 Ah (ampere-hours) ofcapacity, the drain is typically 25-microamperes, giving a battery atheoretical lifetime of 80 000 hours. In reality, however, they seldomlast longer than 5 years.

As one may see, the main problems related to PM treatment are related tothe battery and to the leads.

Several attempts have been made to solve these problems.

For instance, W. H. Ko, in U.S. Pat. No. 3,456,134, as published Jul.15, 1969, discloses a piezoelectric converter for converting body motionto electrical energy for driving electrical implants, such as a PM. Kofound that this piezoelectric system may deliver enough energy to run aPM when driven at a mechanical pulse rate and with a motion similar tothe heart motion of an animal, upon which it was tested. However he didneither suggested to integrate a piezoelectric system in a PM itself norto implant such a conversion device in a heart. As nearly 40 years havepassed since the disclosure of Ko, and no commercially available PMsusing Kos principle have become available, it is regarded that theskilled person in the field of implanted devices does not regard that itis feasible to carry out Kos piezoelectric system with implantabledevices.

U.S. Pat. No. 6,654,638 discloses ultrasonically activated electrodesthat generally use a piezoelectric energy converter to convert energyfrom an external energy source, e.g. an ultrasonic element. This energyis stored within the electrode. It is also mentioned that the electrodesmay use the contracting heart to produce energy by compressing ordeflecting a piezoelectric element. However, the electrodes disclosed inU.S. Pat. No. 6,654,638 are always controlled by an external device.That means pacing action is not possible by the electrode itself withoutthe interaction with an external control unit. Furthermore, also thepiezoelectric element is integrated into the housing of the electrode,whereby the piezoelectric element uses valuable space of the housing'ssurface that no longer is available for use as an electrode surface.

Hence, there is a need for a device which alleviates or avoids problemssuch as, but not limited to, those mentioned above, and which device isfully implantable in the body, such as in the vicinity of, or inside,the heart, of a patient, which device may be used for instance for CHFcases, but also in acute situations in the intensive care unit forpatients suffering from acute heart failure, for instance after largemyocardial infarctions, after catheter based coronary artery operationor after cardiac surgery, which device is in no need of battery (orbatteries) or lead(s), which device may continuously monitor the heartfunction and may initiate early medical counter measures.

SUMMARY OF THE INVENTION

Accordingly, the present invention preferably seeks to mitigate,alleviate or eliminate one or more of the deficiencies in the art anddisadvantages, such as the above-identified, but not limited to, singlyor in any combination, and solves problems, such as theabove-identified, but not limited to, by providing a device according tothe appended patent claims.

For this purpose an intra cardiac device of this kind according to claim1, is characterized by means for transforming kinetic energy from heartmuscle movement into electrical energy in use, from which electricalenergy information in respect of heart function is obtainable.

Advantageous features of the invention are defined in the dependentclaims.

More specifically, according to a first aspect of the invention, anintra cardiac device for heart function intervention is provided thatcomprises means for transforming kinetic energy from heart tissuemovement into electrical energy in use, from which electrical energyinformation in respect of heart function is obtainable.

The means for transforming kinetic energy into electrical energy may bea magnet, movable relative a coil.

The means for transforming kinetic energy into electrical energy may bea rotatable pendulum, communicating with a magnet, rotatable relative acoil.

The means for transforming kinetic energy into electrical energy may bea piezo-electric energy converter.

The intra cardiac device may comprise an energy storage means, such as acapacitor, adapted to store the transformed electrical energy for use bythe intra-cardiac device.

The intra cardiac device may comprise a wireless transmitter ortransceiver.

The intra cardiac device may comprise fixation means, for attachment ofsaid device in or at the heart, such as a stent, tines or hooks, or ascrew.

The intra cardiac device may comprise elutionable steroids.

The intra cardiac device may be configured to provide device functionrelated data, such as administrative data, programmed data like mode,cardiac stimulation pacing rate, defibrillation energy, power unitcondition.

The information may be information in respect of heart function such asmeasured data like heart rate, heart movement amplitude, heart movementacceleration, electrical heart rate, electrical signal amplitude, ordata related to previous cardiac events stored in the intra cardiacdevice.

The intra cardiac device may be an electrical cardiac stimulator device,such as an implantable pacemaker, a cardioverter defibrillator or adefibrillator.

The intra cardiac device may comprise at least one electronic circuit.

The electronic circuit may comprise pacing algorithms and/ordefibrillating algorithms.

The intra cardiac device may comprise a positive and a negativeelectrode.

The positive and a negative electrode may be configured to obtainelectrical heart signals.

The electrical energy may in use of the intra cardiac device be storedin an energy storage means, wherein the energy storage means may beconfigured to provide energy stored therein for cardiac stimulation viasaid positive and negative electrode when electrical heart signals arenot obtained via said positive and negative electrode.

The poles may be made of good electrically conducting material.

The poles may be made of copper or steel or a polymer.

At least one of said poles may be covered with porous material.

The porous material may be activated carbon, sintered platinum-iridiumor sputtered titanium-nitride.

The heart tissue may be a heart muscle.

The intra cardiac device may be a leadless (no external lead asconventionally known) and batteryless self-contained intra cardiacmonitoring and/or intra cardiac stimulating heart device capable ofwireless communication with other intra cardiac or extracorporealdevices.

According to a second aspect of the invention, a system is provided. Thesystem comprises at least one intra cardiac device according to thefirst aspect of the invention, and at least one receiver, wherein the atleast one intra cardiac device comprises means of communication, throughwhich said at least one device may communicate wirelessly with said atleast one receiver.

The at least one receiver may be an extracorporeal receiver locatedoutside a patients body in use of said system having said at least oneintra cardiac device implanted therein.

The at least one receiver may be located in a mobile terminal such as amobile telephone, a fix-net telephone, an intensive care monitor, apacemaker, a defibrillator, an infusion pump, or a transceiver of atelemetry system.

The system may comprise a plurality of said intra cardiac devices and afirst intra cardiac device of said plurality of intra cardiac devicesmay be configured to communicate with a receiver located in a secondintra cardiac device of said plurality of intra cardiac devices.

The intra cardiac device of the system may be configured to communicateinformation in respect of heart function derived from electrical energyinformation originated during conversion from kinetic heart movementenergy to electrical energy to the receiver.

The means of communication may be wireless communication selected fromthe group comprising of wireless radio transmission including Bluetooth®or ZigBee®, and ultrasound communication, or combinations thereof.

The system may further comprise a delivery system for an intra cardiacdevice, wherein the delivery system comprises an intra cardiac deviceaccording to the first aspect of the invention, an introducer sheath(78), a guide wire (76), a diagnostic catheter (102), and a deliverycatheter (94).

According to another aspect of the invention, a method of communicationbetween a first intra cardiac device according to the first aspect ofthe invention and a receiver is provided. The method comprisestransforming kinetic energy from heart tissue movement into electricalenergy, deriving information obtained from said transformed electricalenergy related to said heart movement, and communicating saidinformation to said receiver wirelessly.

The method may further comprise using said information to electricallyinstruct a second intra cardiac device.

The method may further comprise using said information in an externaldata assembly equipment for monitoring said heart movement.

According to yet another aspect of the invention, a method formonitoring heart function is provided. The method comprises convertingkinetic energy from heart tissue movement to electrical energy, andusing information related to said electrical energy as an indicator ofsaid heart function.

The method may further comprise wirelessly communicating saidinformation related to the electrical energy to a receiver forinterpretation.

The receiver may be located in an external data assembly equipmentoutside of the patient body.

The external data assembly equipment may be a mobile terminal such as amobile telephone, or a fix-net telephone line, an intensive caremonitor, an infusion pump or a transceiver of a telemetry system.

According to still another aspect of the invention, a method oftreatment of heart blocks and arrhythmias is provided. The methodcomprises transforming kinetic energy from heart tissue movement intoelectrical energy, and deriving information obtained from saidtransformed electrical energy related to said heart movement, by the useof at least one intra cardiac device according to a first aspect of theinvention; and obtaining electrical heart signals from said at least oneintra cardiac device, and stimulating the heart electrically by at leastone intra cardiac device with at least a part of the transformedelectrical energy.

The first intra cardiac device may communicate with at least a secondintra cardiac device.

The first intra cardiac device may act as a master device and the atleast second intra cardiac device may act as a slave device.

According to yet a further aspect of the invention, a method ofmonitoring congestive heart failure is provided. The method comprisestransforming kinetic energy from heart tissue movement into electricalenergy by the use of at least one intra cardiac device according to afirst aspect of the invention, deriving information obtained from saidtransformed electrical energy related to said heart movement, andcommunicating said information to a receiver wirelessly.

According to yet another aspect of the invention, a method forpositioning a system comprising any of the intra cardiac devicesaccording a first aspect of the invention is provided. The methodcomprises positioning said intra cardiac device in the right ventricle(RV), in the middle cardiac vein or in the coronary sinus, positioning asecond intra cardiac device inside the LV from the aorta, in the lateralmarginal veins, in the great cardiac vein or in the coronary sinus, andpositioning a third intra cardiac device inside the wall of the rightatrium or right atrium appendage, wherein each of these intra cardiacdevices implemented as units in a system will communicate with eachother.

The method may further comprise positioning a fourth intra cardiacdevice, implemented as a defibrillator, inside the RV, the marginalveins, the great cardiac vein 4, the coronary sinus 2 or in the middlecardiac vein 10, which fourth intra cardiac device also will communicatewith said first, second, and/or third intra cardiac device.

The intra cardiac devices may be attached to the heart surface directlyfor optimizing positioning, according to the method.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which the inventionis capable of will be apparent and elucidated from the followingdescription of embodiments of the present invention, reference beingmade to the accompanying drawings, in which

FIG. 1 is a schematic illustration showing a human heart;

FIG. 2 is a schematic illustration showing a pacemaker or prior artmonitoring device 36 like a HeartPod from Savacor Inc., a Chroniclesystem from Medtronics or a Pacemaker implanted at a patients shoulderarea, remote from the heart. A lead for transportation of electrons runsfrom the implant can to the pressure transducer and back or in the caseof a pacemaker to the heart tissue where the electron transfer takesplace from the lead tip. These devices have a battery in the can;

FIG. 3 is a schematic block diagram showing an intra cardiac deviceaccording to an embodiment of the present invention, wherein the deviceis capable of communicating with an external communication unit, e.g.outside the patient, via an integrated communication unit;

FIG. 4 a) is a schematic illustration showing an intra cardiac deviceproducing electricity by means of induction;

FIG. 4 b) is a schematic illustration showing another intra cardiacdevice producing electricity by means of induction;

FIG. 5 a) is a schematic illustration showing tines as fixation meansfor an intra cardiac device;

FIG. 5 b) is a schematic illustration showing a screw as fixation meansfor an intra cardiac device;

FIG. 5 c) is a schematic illustration showing a stent as fixating meansfor an intra cardiac device, the stent pushing the device against avessel wall and still leaving the lumen open for sufficient flow;

FIG. 6 a) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention implemented with fixationtines;

FIG. 6 b) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention having a fixation screw;

FIG. 7 a) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention delivered and fixed in theanterior inter-ventricular vein;

FIG. 7 b) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention delivered and fixed in thelateral marginal vein;

FIG. 7 c) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention delivered and fixed in themiddle cardiac vein;

FIG. 7 d) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention delivered and fixed in theright ventricle;

FIG. 7 e) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention delivered and fixed in theleft ventricle;

FIG. 7 f) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention delivered and fixed on theheart surface;

FIG. 8 is a schematic block diagram of showing an intra cardiac deviceaccording to an embodiment of the invention having an energy unitpowering a cardiac stimulator in the form of a pacemaker;

FIG. 9 is a schematic illustration showing a complete pacemaker systemimplemented with four intra cardiac device according to embodiments ofthe invention implemented as pacemaker units are implanted in thelateral marginal vein, the middle cardiac vein, in the right ventricleand in the right atrium appendage, respectively, and a further intracardiac device according to an embodiment of the invention implementedas a defibrillation unit is located in the great cardiac vein, whereinthe devices may communicate with each other and outside the patient bymeans of the built in communication units;

FIG. 10 a) is a schematic illustration showing access to the vein systemthrough the internal Jugular vein;

FIG. 10 b) is a schematic illustration showing access to the vein systemthrough the femoral vein;

FIG. 10 c) is a schematic illustration showing access to the leftventricle through the femoral artery;

FIG. 11 is are schematic illustrations showing a delivery system forfixation with tines and a screw respectively;

FIG. 12 is a schematic illustration showing a delivery system forfixation with stent;

FIG. 13 is a schematic illustration showing the insertion of a guidewire into the coronary sinus through the internal Jugular vein;

FIG. 14 a) is a schematic illustration showing a guide wire and aguiding catheter introduced through the coronary sinus, the greatcardiac vein and into the anterior inter-ventricular vein;

FIG. 14 b) is a schematic illustration showing an intra cardiac deviceaccording to an embodiment of the invention delivered in the greatcardiac vein by means of a stent; and

FIG. 15 is a schematic illustration showing a complete heart functionmonitoring system according to an embodiment of the invention with anexternal communication unit.

EMBODIMENTS OF THE INVENTION

The following description focuses on embodiments of the presentinvention applicable to a device, and in particular to a method of usingsaid device, for transforming kinetic energy of a heart 1 intoelectrical energy. The device may transmit data outside the body.However, it will be appreciated that the invention is not limited tothis application but may be applied to many other embodiments.

It will be understood that the Figures are merely schematic and are notdrawn to scale. For clarity of illustration, certain dimensions may havebeen exaggerated while other dimensions may have been reduced. Also,where appropriate, the same reference numerals and letters are usedthroughout the Figures to indicate the same parts and dimensions.

In one embodiment the device according to the present invention is anintra cardiac device for heart function intervention. This device hasthe capability to transform kinetic energy obtained from heart musclemovement into electrical energy in use. This electrical energy may thenbe used to obtain information in respect of heart function.

The term “intervention” is, in this context, meant to be interpreted asmonitoring, modifying, surveying, and/or controlling heart function andaction.

In one embodiment of the present invention the herein presented deviceis designed to be implanted totally in the heart itself. Since the heartis constantly moving vigorously in all three dimensions, a deviceprovided in the heart has a certain potential kinetic energy. Withmodern technology, e.g. micro mechanical systems, such kinetic energymay be detected and transformed into electrical energy. Since the heartnever stops, it is not necessary to save any energy in batteries, ifnecessary possibly only momentarily in a capacitor. The electrical drainof 25 microamperes according to the prior art mentioned above includesthe energy loss in the lead, thus the energy needed in a leadless systemis much lower than that with a lead.

Modern technology permits new solutions for transforming kinetic energyinto electrical energy by means of Micro Electro Mechanical Systems,also called MEMS. These new solutions may be implemented in respect ofthe embodiments according to the present invention. There are differentmethods to transform kinetic energy into electrical energy, by using anenergy conversion unit 5.

Electrical energy may be obtained by means of unit 5 by inductiveconversion from kinetic energy. In this case, a magnet 52 is movingrelative a coil 50, whereupon a voltage and current is generated in thecoil 50. Magnet 52 for instance may be connected via a connection meanssuch as a rod 48 and a gearbox to a pendulum 46 for converting hearttissue movements in three dimensions to a suitable movement of themagnet 52 relative coil 50. This may be achieved by moving a magnet 52back and forth through the coil 50, as suggested by Lee et al 2003, in“AA Size micro Resonators”. Lee demonstrated that up to 830 microwattscould be achieved with such a conversion device.

Therefore, in one embodiment of the present invention, electrical energyis achieved by moving a magnet 52 back and forth relative a coil 50.

Another energy conversion solution is to transform movements of amagnetic pendulum 46 in another embodiment of energy conversion unit 5into rotation and then have the magnet 52 to rotate in the coil 50. TheSeiko watch, a self winding electric watch, is an example that mayproduce up to 1 mW. A spring like in a self winding wrist-watch and agear system might accelerate the rotational speed to 15000 rev/min, anoptimal rate. Kula and Najafi could achieve 2.5 microwatt at 10 Hz in aMEMS. Hence, a pendulum of 2 g is sufficient to convert enough energy tosupply a pacemaker, such as a pacemaker unit 70. In this respect, oneembodiment of the present invention transforms movements of a magneticpendulum 46 into rotation, and then have the magnet to rotate in a coil50 to obtain electrical energy.

Piezo-electrical materials may produce an electrical current with nomechanical parts moving. Pressure on a piezo-electrical materialproduces a voltage. Roundy, 2003, produced 0.2 mW on a 1 cm cube @ 120Hz. Capacitive or electrostatic methods might also be used. The housingof the intra cardiac device may comprise piezo electric elements for theenergy conversion. However, in this case a part of the housing area isblocked for other use, e.g. as electrode surface. As the intra cardiacdevice is very compact, housing surface is rather limited. Moreover, thehousing itself has to be exposed to a pressure from the moving hearttissue. When the device is attached to the tissue, this is difficult toimplement. Therefore, it is proposed to have a piezo electric conversionmeans inside the housing, which is exposed to a mechanical pressure whenthe heart tissue accelerates. For instance, a T-bar like element whichgenerates a lever on a piezo electric element due to resulting inertiaof a lever perpendicularly arranged to the piezo element may be used forpiezo electric energy conversion. Accordingly, some embodiments of theinvention are implemented by using piezo-electrical, capacitive orelectrostatic energy conversion methods in embodiments of energyconversion unit 5.

Hence, a self-contained implantable intra cardiac device may be providedaccording to some embodiments.

The device according to some embodiments of the present inventionprovides the possibility to continuously monitor the heart function andinitiate early intervention, if the heart condition of a patient isdeteriorating. An energy device fully implantable monitors in use thekinetic energy of a heart 1 and continuously transmit a report of thecondition of the heart 1 to a receiver outside the body or to anotherdevice inside the body, for instance a pacemaker, such as a pacemakerunit 70, a defibrillator or an infusion pump able to adjust the amountof diuretics to be injected. For this purpose, energy conversion unit 5is via communication element 9, e.g. by wires or wirelessly, connectedto a communication unit 7 inside a housing 11 of the intra cardiacdevice 3, as shown in FIG. 3.

According to a specific embodiment, the device is self-contained anddoes not communicate with an extracorporeal device. The device accordingto this embodiment continuously monitors the heart function and initiateearly intervention, if the heart condition of a patient isdeteriorating. The device is in use fully implanted in the heart 1 andconverts kinetic energy from heart movements into electric energy. Theconversion signal provides information to monitor the kinetic energy ofthe heart 1 and continuously analyzes this information in order toactivate a pacing circuitry if required.

A device according to one embodiment of the present invention may alsobe used in acute situations in the intensive care unit for patientssuffering from acute heart failure, for instance after large myocardialinfarctions, after catheter based coronary artery intervention or aftercardiac surgery. By means of the device according to the embodiment ofthe present invention, the kinetic energy of the heart 1 is transformedinto electricity; the amount of electrical energy achieved is related tothe force of movement of the heart 1, an indicator of the heartcondition. More specifically, an electrical signal is obtained whenconverting the heart movement kinetic energy into electrical energy. Theelectrical signal has a characteristic electrical voltage and currentover time. For instance, the maximum amplitude of the electrical signalmay deliver information how fast the heart 1 is accelerating. The curveform may give information how the muscle exactly is accelerating, etc.Furthermore, no energy is transferred to the herein presented inventivedevice from outside the heart 1.

In respect of the PM's according to the prior art, the herein presenteddevice, according to some embodiments of the present invention,eliminates among others the problems related to batteries and leads,since there is no battery and there are no leads comprised in the hereinpresented PM.

In a first embodiment an energy unit is utilizing induction for creatingelectricity electromagnetic, by transforming the kinetic energy of theheart movements. This is achieved either by moving a magnet back andforth relative a coil 50, e.g. through the coil 50, or by rotating amagnet 52 relative a coil 50, e.g. by rotating a magnet 52 in a coil 50or by rotating a coil 50 around a magnet 52, e.g. by means of a pendulumeffect.

In a second embodiment electric current unit is utilizing apiezo-electric material, i.e. a material that creates an electriccurrent when deformed.

In still another embodiment an energy unit is created utilizingelectrostatic or capacitive technology.

The amount of electricity produced is an indicator of the kinetic energyof the heart 1 reflecting acceleration and movement of the site wherethe device is implanted. Acceleration and movements are indicators ofthe heart muscle condition at a given time. According to someembodiments, the device has a transmitter emitting a signal to areceiver, e.g. outside the body. Thus, the device according to someembodiments comprises an energy unit, an electronic control unit, atransmitting unit and fixation means. Some embodiments of the device mayalso comprise a transmitting and receiving unit (also called transceiverunit) instead of only a transmitting unit.

The receiver may also be incorporated in another device according toanother embodiment of the invention. Thus, one implanted device maycommunicate with another implanted device, e.g. to give the otherimplanted device instructions in respect of when and how to act. Forinstance, a first implanted device may convert kinetic energy, analyzeheart condition, and send a signal to a second implanted device if aheart failure is detected. The second device also converts kineticenergy for powering a receiver and a pacing circuit. When the secondimplanted device receives a signal from the first implanted device, e.g.that pacing is necessary, the second implanted device takes appropriateaction.

In one embodiment wireless communication is provided by means of radiofrequency (RF) transmission which may be digitally coded.

In one embodiment the means of communication is provided by so calledBluetooth® technology.

ZigBee® technology might also be used in other embodiments. ZigBee® is apublished specification set of high level communication protocolsdesigned to use small, low power digital radios based on the IEEE802.15.4 standard for wireless personal area networks (WPANs). Thetechnology is designed to be simpler and cheaper than other WPANs suchas Bluetooth®. The most capable ZigBee® node type is said to requireonly about 10% of the software of a typical Bluetooth® or WirelessInternet node, while the simplest nodes are about 2%. ZigBee® providesan inexpensive self-organizing mesh network. However, it has not yetbeen envisaged for use in implanted medical devices. ZigBee® is designedto use very small amounts of power. This makes ZigBee® perfectly suitedfor use in the implantable cardiac devices of the present invention.

In still another embodiment ultrasound may be used for wirelesscommunication with the intra cardiac device(s).

The data retrieved outside may be exact numeric data of a current statusor may also only comprise trends.

In another embodiment a device and a method for treatment of heartblocks and arrhythmias by means of an electrical cardiac stimulatorwithout battery and leads are presented. The device (FIG. 8) is designedto be completely implanted in a heart 1 or on a heart surface. In thisembodiment the device comprises five main components: an energyconversion unit 5, an electronic control circuit 700, an electrodecontact surface 701 towards the heart tissue, a communication unit 7 andfinally means for attachment or fixation in or to the heart 1.

In one embodiment of the intra cardiac device according to the presentinvention in the form of an electrical cardiac stimulator, an energyunit is utilizing induction for creating electricity by means ofelectromagnetically converting kinetic energy from heart movement intoelectrical energy. This is achieved either by moving a magnet 52 backand forth relative a coil 50 or by rotating a magnet 52 relative a coil50, e.g. by rotating a magnet 52 in a coil 50 or by rotating a coil 50around a magnet 52, e.g. by means of a pendulum effect.

In another embodiment of the electrical cardiac stimulator according tothe present invention, an energy conversion unit is utilizingpiezo-electric material, a material that creates an electric currentwhen deformed.

In still another embodiment of the electrical cardiac stimulatoraccording to an embodiment of the present invention, an energyconversion unit is based on electrostatic or capacitive conversiontechnology.

According to one embodiment, the electrical cardiac stimulator'selectronic circuit utilizes traditional PM algorithms on an electronicchip. The chip may for instance be of rectangular or square surfacearea, and by estimation the complete area is with current technologyless than approximately one square centimeter in size. Furtherminiaturization is envisaged with emerging technologies. The device hastwo electrode contact surfaces, preferably one at each end of theimplant, one positive pole receiving the electrons and one negativeemitting electrons into the heart tissue. The electrode contact surfacesare made of good electrically conducting metal material like copper orsteel or other alloys. They may be covered with porous material likeactivated carbon, sintered platinum-iridium or sputteredtitanium-nitride. The current is concentrated in a small area of contactwith the myocytes by means of designing the geometrical surface area ofcontact of the electrodes as small as is optimal. The surface may alsobe eluting steroids like dexamethasone from the surface initially inorder to limit inflammation during healing in. The electrical cardiacstimulator device has a unit of communication. The communication unit 7may communicate with communication units in other devices implanted inthe same heart 1, e.g. one in an atrium and one in a ventricle, or oneelectrical cardiac stimulator in the implementation of a PM unit and oneelectrical cardiac stimulator in the implementation of an ICD unit.Thus, one unit may serve as a master and the others are slaved to themaster. Thus, one device may communicate with another device, e.g. togive the other device instructions in respect of when and how to act.The communication unit 7 may also be designed to communicate outside ofthe patient. Communication may occur one-way out of the device in orderto deliver information from the implanted device (in this case thedevice has a transmitter only), or two-way so that the implanted devicealso may receive information (in this case the device has atransceiver). In either case information that is transmitted maycomprise information related to follow up of the device's function andfor adjustments of it's mode of operation, for instance administrativedata, programmed data like mode, rate etc., measured data like heartrate, mechanical cardiac function values, like local acceleration at theimplanted devices location, or the electrical pulse rate, electricalpulse amplitude, power unit condition etc., or stored data. The means ofcommunication is based on wireless transmission technologies. In oneembodiment the means of communication is by means of radio frequency(RF) waves. Communication may be digitally coded and/or authenticated inorder to provide a secure and reliable data transmission to and/or fromimplanted device(s).

In another embodiment of the electrical cardiac stimulator deviceaccording to the present invention the means of communication is basedon so called Bluetooth® technology. The new ZigBee® technology may alsobe used in respect of the presently described electrical cardiacstimulators.

In still another embodiment of the electrical cardiac stimulator deviceaccording to the present invention ultrasound transmissions through thebody may be used for wireless communication to/from the implanteddevice(s).

Again Nanotechnology and MEMS may be utilized for minimizing thecommunication unit 7 in the device.

In yet another embodiment the intra cardiac device according to thepresent invention is a congestive heart failure monitoring device 3. Thecongestive heart failure monitoring device 3 is intended to be insertedand fixated adjacent to the left ventricle of the heart 1. Preferablythe device is inserted in the vein system through the coronary sinus 2and the great cardiac vein 4 into smaller branches along the lateralwall of the left ventricular wall 26. Other positions in the vein systemare in the anterior inter-ventricular vein on the front of the heart 1or in the middle cardiac vein 10 behind the heart 1 between the left andthe right ventricle, or in the great cardiac vein 4. In cases of rightheart failure separately, the device is placed close to the rightventricle, in case only one embodied device is implanted.

In the Figures, e.g. FIG. 1, furthermore the following elements areillustrated for a better understanding of the present invention:anterior inter-ventricular vein 8, left atrium appendage 14, pulmonaryartery 16, superior vena cava (SVC) 20, right ventricular wall 24,tricuspid valve 32, mitral valve 34, right atrium appendage cavity 74,the femoral artery 84, the iliac artery 86, the aorta 88 and theinferior vena cava (IVC) 90.

The positioning of electrical cardiac stimulator devices, such aspacemaker (PM) devices, for example a pacemaker unit 70, according toembodiments of the present invention may also be more diverse ordistributed over the heart 1, depending on the function of the differentcomponents of a electrical cardiac stimulator system. For instance afirst intra cardiac device implemented as a PM for stimulation of theright ventricle (RV) may be positioned inside the RV, in the middlecardiac vein 10 or in the coronary sinus 2. A second intra cardiacdevice implemented as PM for stimulation of the left ventricle (LV) mayadditionally be positioned inside the LV from the aorta 18, in thelateral marginal veins 6, in the great cardiac vein 4 or in the coronarysinus 2. A third intra cardiac device implemented as a PM forstimulation of the right atrium 22 may additionally be positioned insidethe right atrium wall or right atrium appendage 12. An intra cardiacdevice implemented as a defibrillator may additionally be positionedinside the RV, the marginal veins, the great cardiac vein 4, thecoronary sinus 2 or in the middle cardiac vein 10. Each of these intracardiac devices implemented as a units will communicate with each other.For instance during open chest surgery, the devices are attached to theheart surface directly, a technique that optimizes positioning.

An embodiment of the method according to the present invention is nowdescribed. The method provides for monitoring of the heart function bymeans of converting kinetic energy from the heart 1 to electrical energyand using information related to the electrical energy, e.g. the amountof electricity produced over time, as an indicator of the heartfunction.

Initially access to the circulatory system is established. Moreprecisely, one specific way is to first establish access to the veinsystem by means of puncturing a large vein with a needle, wherein suchveins might be the cubital arm vein, the cephalic vein, the internaljugular vein 78, the subclavian vein, the femoral vein 82 or any othervein large enough. Subsequently, a guide wire 76 is inserted and anintroducer sheath 78 with a hemostatic valve is placed over the wire.The guide wire 76 is then withdrawn. A diagnostic catheter 102 isinserted in the introducer sheath 78 to the location intended forpositioning the device in the body. Preferably the catheter is insertedin the vein system through the coronary sinus 2 and the great cardiacvein 4 into smaller branches along the lateral wall of the leftventricular wall 26, the lateral marginal branches. Other suitablepositions in the vein system are for instance in the anteriorinter-ventricular vein on the front of the heart 1 or in the middlecardiac vein 10 behind the heart 1 between the left and the rightventricle. Once the diagnostic catheter 102 is in position an angiogramof the vein system is achieved using contrast dye. By interpreting theimage from the angiogram of the vein, the proper position for the deviceis determined. A guide wire 76 is now advanced to the selected positionin the vein and beyond, whereupon the diagnostic catheter 102 iswithdrawn, leaving the guide wire 76 in position. Over the guide wire 76a guiding catheter is advanced to the deployment site or adjacent. Nowthe delivery system 92 is advanced over the guide wire 76 but inside theguiding catheter to the desired site. If the device is kept inside thedelivery system 92 by means of a restraining catheter, this is nowretracted, thereby exposing the device that is expanding inside thevein, e.g. by a shape memory effect. This shape memory effect may forexample be accomplished by polymers that present this feature, or withother suitable materials such as nitinol, which is a nickel-titaniumalloy presenting this feature. The device may thus fixate itself at theselected position, or in case the device has tines 56 the tines 56 willattach into the vein wall, keeping the device strongly fixated. In casethe device has a screw 58 for fixation in the tissue, the deliverysystem 92 is rotated in the proper direction until the screw 58 issolidly attached in the heart tissue. In case the fixation means is astent 60 made of stainless steel, or another alloy, without shapememory, the fixation in the vessel is made by inflating a balloon insidethe stent 60 for stent expansion. A pushing rod 96, a pushing catheter98, and an X-ray marker 100 are further elements used for certain of theherein described procedures.

If the device is to be deployed in a cavity like the RV 62, LV 64 or theright atrium 22, the same actions as above are executed until theguiding catheter and the delivery system 92 is in position inside thecavity. The device is advanced and in case of a screw attachment thedelivery system 92 is rotated in the proper direction until the devicehas a strong attachment in the heart tissue wall. In case the device hasfixation tines 56 on the outside a place between the papillary muscles28 or between the trabecles of the heart muscle 30 is located where thetines 56 get a good attachment and then the device is released from thedelivery system 92 by retracting the delivery catheter 94 from over thedevice.

Other fixation means are for instance eyelets 66 or a suture 68, asshown in FIG. 7 f.

Once the intra cardiac energy and monitoring device 3 is in the properposition the movements of the heart 1 produce a certain amount ofelectricity in the device. This is done by converting kinetic energyfrom the heart movement into electric energy, as described above.

The communication unit 7 of the intra cardiac device may transmitinformation to a receiver or an external communication unit 104, e.g.outside of the body or in other implanted intra-cardiac devices. Theinformation may be used for interpretation of the current or previousheart condition. The external communication unit 104 may comprise anantenna 106, which may be integrated inside a housing of unit 104, and adisplay 108 for visualization of information.

The receiver outside of the body may be part of or connected to a mobiletelephone or a fix-net telephone line for direct communication to aphysician or a nurse for monitoring purposes and for taking the rightactions. The receiver might also be a part of or connected to intensivecare monitors. The receiver might be a handheld unit and also have analgorithm and display suggesting to the patient directly the currentstatus and which actions to take.

A method according to another embodiment of the present invention isdescribed for insertion of and establishing a electrical cardiacstimulator system, such as a pacemaker (PM) system, without leads orbattery by means of converting kinetic energy from the heart 1 toelectricity and using the a certain amount of the electricity producedfor stimulating the heart 1 electrically securing a safe heart rhythm.The same method is applied for positioning of electrical cardiacstimulator devices implemented as defibrillation devices.

First access to the vein system is established by means of puncturing alarge vein with a needle, such veins might be the cubital arm vein, thecephalic vein, the internal jugular vein 80, the subclavian vein, thefemoral vein 82 or any other vein large enough. A guide wire 76 is theninserted and an introducer sheath 78 with a hemostatic valve is placedover the guide wire 76. Subsequently the guide wire 76 is withdrawn.Then a diagnostic catheter 102 is inserted to a location intended forpositioning the device. For instance for LV pacing, the catheter may beinserted in the vein system through the coronary sinus 2 and the greatcardiac vein 4 into smaller branches along the lateral wall of the leftventricular wall 26, the marginal branches. Other positions in the veinsystem would be in the anterior inter-ventricular vein on the front ofthe heart 1 or in the middle cardiac vein 10 behind the heart 1 betweenthe left and the right ventricle.

Once the diagnostic catheter 102 is in position an angiogram of the veinsystem is achieved using contrast dye. By interpreting the image fromthe angiogram of the vein, the proper position for the device isdecided. A guide wire 76 is now advanced to the selected position in thevein and beyond, whereupon the diagnostic catheter 102 is withdrawn,leaving the guide wire 76 in position. Over the guide wire 76 a guidingcatheter is advanced to the deployment site or adjacent. Now thedelivery system 92 is advanced over the guide wire 76 but inside theguiding catheter to the desired site. If the device is kept inside thedelivery system 92 by means of a restraining catheter, this is nowretracted, exposing the device that is expanding inside the vein andfixating itself there, or in case the device has tines 56 the tines 56will attach to the vein wall, keeping the device strongly fixated. Incase the device has a screw 58 for fixation in the tissue, the deliverysystem 92 is rotated in the proper direction until the screw 58 issolidly attached to the tissue. If the device has tines 56 for fixationthey will engage the vein wall for secure anchoring. If the device is tobe deployed in a cavity like the RV 62, LV 64, the right atrium 22 orthe appendage of the right atrium 12, the same actions as above areexecuted until the guiding catheter and the delivery system 92 is inposition inside the cavity. The device is advanced and in case of ascrew attachment the delivery system 92 is rotated in the properdirection until the device has a strong attachment in the wall. In casethe device has fixation tines 56 on the outside a place between thepapillary muscles 28 or the muscular trabecles is located where thetines 56 get a good attachment and then the device is released from thedelivery system 92 by retracting the delivery catheter 94 from over thedevice. In case the electrical cardiac stimulator system comprisesseveral electrical cardiac stimulator devices, the procedure describedabove is repeated for each of the device members of the system by meansof repositioning the guide catheter in the desired positions until allthe devices in the system have been deployed. Once all electricalcardiac stimulator device, such as pacemaker, for example pace makerunit 70, and defibrillator devices, are in the proper positions themovements of the heart 1 will induce a certain amount of electricity ineach of the devices. The devices are now able to communicate with theothers. One of the devices, for instance an electrocardiogram detectingdevice may take the lead and run the operation of the system. Thetransmitting system of each of the devices or the leading device onlywill send the information to a receiver or a communication unit 7outside of the body for interpretation and setting mode of operation bymeans of transmitting back to the device(s). The receiver outside of thebody may be part of or connected to a mobile terminal or a fix-nettelephone line for direct communication to a physician or a nurse formonitoring purposes and for taking the right actions. For instance mostmobile terminals in the form of mobile telephones have an integratedBluetooth wireless communication port. Embodiments of the intra cardiacdevice having a Bluetooth transmitter or transceiver may directlyconnect to such a mobile telephone according to a simple pairing routinematching the phone and the implanted device for communication. Once thislink is established, data communicated via the Bluetooth link may easilybe forwarded to or received via the mobile networks connection of themobile phone enabling a multitude of operations including maintenanceactions or reprogramming of the implanted devices.

The external receiver communicating wirelessly with the implanted intracardiac device may also communicate information via a distributednetwork, like the Internet, e.g. to a physician for examination.

The external receiver might also be a part of or connected to intensivecare monitors or telemetry systems. In the first case data from theintra cardiac devices may be displayed on the intensive care monitor.Often intensive care monitors are embedded in a network providing e.g.data storage, print outs etc., or even access to and from a HospitalInformation System.

Connecting intra cardiac devices of embodiments of the inventionwirelessly to telemetry systems provides a number of advantages comparedwith today's telemetry systems. Especially the patient telemetry unitsdo no longer need ECG electrodes taped to the patient. Existingtelemetry systems may be used with a simple transceiver outside thepatient body managing communication both with the implanted intracardiac device(s) and the fixed installed telemetry system. In thismanner a convenient continuous monitoring of a patient is provided rightaway from the end of implantation. This may contribute to cost saving inhealthcare as patients that have undergone cardiac surgery may bedirectly submitted to non-critical care units.

The invention may be implemented in any suitable form, and the elementsand components of an embodiment of the invention may be physically,functionally and logically implemented in any suitable way. Indeed, thefunctionality may be implemented in a single unit, in a plurality ofunits or as part of other functional units. As such, the invention maybe implemented in a single unit, or may be physically and functionallydistributed between different units.

Although the present invention has been described above with referenceto specific embodiments, it is not intended to be limited to thespecific form set forth herein. Rather, the invention is limited only bythe accompanying claims, and other embodiments than the specific aboveare equally possible within the scope of these appended claims.

In the claims, the term “comprises/comprising” does not exclude thepresence of other elements or steps. Furthermore, although individuallylisted, a plurality of means, elements or method steps may beimplemented. Additionally, although individual features may be includedin different claims, these may possibly advantageously be combined, andthe inclusion in different claims does not imply that a combination offeatures is not feasible and/or advantageous. In addition, singularreferences do not exclude a plurality. The terms “a”, “an”, “first”,“second” etc do not preclude a plurality. Reference signs in the claimsare provided merely as a clarifying example and shall not be construedas limiting the scope of the claims in any way.

The invention claimed is:
 1. A leadless, batteryless, self-contained,intra cardiac device for heart function intervention, said devicecomprising: an energy converting means for transforming kinetic energyinto electrical energy, wherein said energy converting means produces anelectrical conversion signal when transforming kinetic energy from hearttissue movement into electrical energy and powers said intra cardiacdevice with said electrical energy and derives measured data in respectof heart function from said electrical conversion signal when the deviceis in use; and a wireless transmitter or transceiver that transmits saidmeasured data to a data receiving device.
 2. The device according toclaim 1, wherein said energy converting means comprises a magnet,movable relative a coil that transforms said kinetic energy into saidelectrical energy and produces said electrical conversion signal.
 3. Thedevice according to claim 1, wherein said energy converting meanscomprises a rotatable pendulum communicating with a magnet that isrotatable relative a coil for transforming said kinetic energy into saidelectrical energy and obtaining said electrical conversion signal. 4.The device according to claim 1, wherein said energy converting meanscomprises a piezo-electric energy converter for transforming saidkinetic energy into said electrical energy and obtaining said electricalconversion signal.
 5. The device according to claim 1, furthercomprising a capacitor to store said electrical energy for use by saiddevice.
 6. The device according to claim 1, further comprising fixationmeans for attachment of said device in or at the heart, wherein saidfixation means is selected from the group consisting of a stent, tines,hooks, a screw, eyelets, and a suture.
 7. The device according to claim1, wherein a surface of said device comprises an elutionable steroid. 8.The device according to claim 1, wherein said device wirelesslytransmits device function related data, administrative data, programmeddata, cardiac stimulation pacing rate, defibrillation energy, and/orpower unit condition via said wireless transmitter or transceiver. 9.The device according to claim 1, wherein said device is an electricalcardiac stimulator device, an implantable pacemaker, a cardioverterdefibrillator, or a defibrillator.
 10. The device according to claim 1,wherein said energy converting means derives said measured data from acharacteristic voltage and current over time of said electricalconversion signal.
 11. The device according to claim 10, furthercomprising at least one electronic circuit that comprises a pacingalgorithm and/or a defibrillating algorithm.
 12. The device according toclaim 1, and further comprising a positive electrode and a negativeelectrode.
 13. The device according to claim 12, wherein said positiveand negative electrodes are configured to obtain electrical heartsignals.
 14. The device according to claim 12, wherein said electricalenergy is stored in an energy storage means when said intra cardiacdevice is in use, and wherein said energy storage means is configured toprovide energy stored therein for cardiac stimulation via said positiveand negative electrodes when electrical heart signals are not obtainedvia said positive and negative electrodes.
 15. The device according toclaim 12, wherein said positive and negative electrodes are made ofcopper or steel or a polymer.
 16. The device according to any of claim12, wherein at least one of said positive and negative electrodes iscovered with porous material.
 17. The device according to claim 16,wherein said porous material is activated carbon, sinteredplatinum-iridium or sputtered titanium-nitride.
 18. The device accordingto claim 1, wherein said measured data is selected from the groupconsisting of heart rate, heart movement amplitude, heart movementacceleration, and combinations thereof.
 19. The device according toclaim 1, wherein said heart tissue is heart muscle.
 20. A systemcomprising said intra cardiac device according to claim 1 and said datareceiving device.
 21. The system according to claim 20, wherein saiddata receiving device is an extracorporeal receiver located outside apatient's body.
 22. The system according to claim 20, wherein said datareceiving device is located in a mobile terminal, a mobile telephone, afix-net telephone, an intensive care monitor, a pacemaker, adefibrillator, an infusion pump, or a transceiver of a telemetry system.23. The system according to claim 20, wherein said intra cardiac deviceaccording to claim 1 is a first intra cardiac device and said datareceiver is located in a second intra cardiac device according toclaim
 1. 24. The system according to claim 20, wherein said wirelesstransmitter or transceiver transmits a signal via radio transmission,Bluetooth®, ZigBee®, ultrasound or combinations thereof.
 25. The systemaccording to claim 20, further comprising a delivery system, saiddelivery system comprising an introducer sheath, a guide wire, adiagnostic catheter, and a delivery catheter.
 26. A method of treatmentof heart blocks and/or arrhythmias, said method comprising: transformingkinetic energy from heart movement into electrical energy using a firstdevice according to claim 1; deriving information obtained from saidelectrical energy related to said heart movement by the use of saidfirst device; and obtaining electrical heart signals from said device,and stimulating the heart electrically by said first device or a seconddevice according to claim 1 with at least a part of said electricalenergy.
 27. The method according to claim 26, wherein said stimulatingthe heart electrically is by said second device and said first intracardiac device communiCates with said second device.
 28. The methodaccording to claim 27, wherein said first device acts as a master deviceand the second device acts as a slave device.